MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problems No Audible Alarm (1019); Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

The customer reported that there is no audible alarm on the system.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

The national support specialist (nss) visited the customers facility to investigate the issue.The nss performed an inspection of the medical devices at the facility.Visual inspection found that multiple devices had broken battery retention tabs, corrosion on lead sets, and improper cleaning damage.The following functional tests were performed: the nss captured logs from a time the issue occurred.The nss also states that he was able to recreate the issue.The nss confirms that the when the device is connected to the network, the appropriate alarms are sent and acknowledged.The nss also confirms that the customer was notified via alarm when the devices lost connectivity.The nss confirms the device damage as the cause of the issue.Good faith effort was performed to obtain additional device serial and part numbers however, this information was not made available.Based on the information available and the testing conducted, the cause of the reported problem was damage to the mx40 device resulting in intermittent ecg waveforms when alarms occurred.The reported problem was confirmed.He customer is working with philips sales team to make a bulk order replacement device purchase.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17571359
• MDR Text Key: 321410179
• Report Number: 1218950-2023-00581
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1